Stapokibart

CHENGDU, China, Feb. 7, 2025 /PRNewswire/ -- KeyMed Biosciences (HKEX: 02162) today announced the National Medical Products Administration (the " NMPA") of China has recently approved the supplemental New Drug Application (the " sNDA") of Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda (康悦达), for the treatment of seasonal allergic rhinitis. The approval is based on a multi-center, randomized, double-blind, placebo-controlled phase III study to confirm the efficacy and safety of Stapokibart injection in treatment of adult patients with seasonal allergic rhinitis who are poorly controlled with nasal corticosteroids or other therapies. The study findings demonstrate that during the pollen season, in comparison with the standard treatment group, which consists of nasal spray hormones combined with antihistamine drugs, the administration of Stapokibart for two weeks effectively controls the typical nasal allergic symptoms of patients, including runny nose, nasal congestion, nasal itching, and sneezing. The least-squares mean (LSMean) of the inter-group difference is -1.3, and its 95% confidence interval (CI) is also -1.3, indicating a highly significant statistical difference (P = 0.0008). This difference far exceeds the minimal clinically important difference (MCID) of 0.23, clearly demonstrating substantial clinical benefits. Moreover, Stapokibart can effectively alleviate ocular allergic symptoms such as eye itching or burning, eye tearing or watering, and eye redness. It comprehensively enhances the quality of life of patients and exhibits excellent safety. About Stapokibart Stapokibart is a high-efficient, humanized antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), and is the first domestically manufactured IL-4Rα antibody drug granted marketing approval by the NMPA. By targeting IL-4Rα, Stapokibart can block both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. IL-4 and IL-13 are two key cytokines that trigger type II inflammation. Stapokibart has demonstrated good safety and encouraging efficacy in multiple previous clinical trials, and its treatment of the indication of moderate-to-severe atopic dermatitis in adults and the indication of chronic rhinosinusitis with nasal polyposis have been approved for marketing in September 2024 and December 2024, respectively. About Keymed Biosciences Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. Keymed was founded by medical and scientific experts who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad. SOURCE Keymed Biosciences Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHENGDU, China I December 23, 2024 I Keymed Biosciences Inc. (HKEX: 02162) today announced the National Medical Products Administration (the “NMPA”) of China has recently approved the supplemental New Drug Application (the “sNDA”) of Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda (康悦达), R&D codename: CM310), for the treatment of chronic rhinosinusitis with nasal polyposis. The approval is based on a multi-center, randomized, double-blind, placebo-controlled phase III clinical study to confirm the efficacy and safety of Stapokibart injection in treatment of patients with chronic rhinosinusitis with nasal polyposis. The study results showed that the data from the phase III clinical trial was positive. Compared to the placebo, Stapokibart significantly reduced nasal polyps (NPS improvement of 2.3 from baseline) and alleviated nasal congestion (NCS improvement of 0.7 from baseline) after 24 weeks. The differences were highly statistically significant (P<0.0001). Additionally, it effectively relieved rhinosinusitis, restored sense of smell, improved nasal symptoms, and enhanced quality of life. It also demonstrated a favorable safety profile. About Stapokibart Stapokibart (trade name: Kangyueda, R&D codename: CM310) is a high-efficient, humanized antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), and is the first domestically manufactured IL-4Rα antibody drug granted marketing approval by the NMPA. By targeting IL-4Rα, Stapokibart can block both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. IL-4 and IL-13 are two key cytokines that trigger type II inflammation. Stapokibart has demonstrated good safety and encouraging efficacy in multiple previous clinical trials, and its treatment of the indication of moderate-to-severe atopic dermatitis in adults has been approved for marketing in September 2024. As of the date of this announcement, the new drug application of Stapokibart for the treatment of seasonal allergic rhinitis has been accepted by the NMPA. SOURCE: Keymed Biosciences